Hamburg’s Public Farewell Includes Rallying Cry For FDA Power
This article was originally published in The Rose Sheet
Outgoing commissioner gives a forceful defense of the agency’s regulatory authority and warns that lowering drug approval standards would be detrimental to both patients and industry.
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Margaret Hamburg’s background in public health, as opposed to academic medicine, was off-putting to some in pharma initially, but she’ll leave the agency in March with high drug approval numbers and praise from industry groups. Chief Scientist Stephen Ostroff has been named acting head, and some speculate that Robert Califf, newly appointed deputy commissioner for medical products and tobacco, is in line to succeed Hamburg on a permanent basis.
Real-World Evidence: CDC Prioritizing Populations, Outcomes For COVID-19 Vaccine Effectiveness Studies
Strategy for assessing how the earliest vaccines to reach market perform beyond clinical trials includes leveraging existing surveillance and data platforms, and employing a diversity of study approaches, CDC epidemiologist says; high-priority areas for study include protection against symptomatic illness among health care workers and prevention of severe disease in the elderly.
Biologics license application is preferred route to market, but if emergency authorization is given it should happen with full transparency and be communicated in a clear manner to strengthen public confidence, National Vaccine Advisory Committee says.